Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with pre- constipation subjects
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000018529
- Lead Sponsor
- TTC Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
(1) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative (2) Subjects currently undergoing treatment with digestive diseases that affect the study or having a surgical history of digestive system (except appendicectomy) (3) Subjects having diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement or a history of these diseases (4) Subjects having a disease requiring treatment or a history of serious diseases, diabetes, hepatopathy, renal or heart disease (5) Subjects having possibilities for emerging allergy related to the study (6) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (8) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (9) Subjects who intend to become pregnant or lactating (10) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (11) Subjects judged as unsuitable for the study by the investigator for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method